A041 DETECTION OF SARS-COV-2 ANTIBODIES IN IMMUNOGLOBULIN PRODUCTS

Abstract

To date, there is limited data on SARS-CoV-2 antibodies in immunoglobulin (Ig) products used in primary immunodefiencies. Here we examined products for evidence of such antibodies. 97 lots of 9 different brands of Ig used in the Mount Sinai infusion center or for home infusions were examined for IgG binding activities against recombinant SARS-CoV-2 receptor binding domain (RBD), spike, and nucleocapsid protein (NP) by ELISA. The area under the binding curves (AUC) was calculated and used for statistical analyses. Cut-off values were determined by the AUC of pre-pandemic samples. Significantly increased AUC values were observed in products with expiration dates of 2023 and 2024, compared to Ig products available in 2020 previously tested in our laboratory. Approximately 60% and 100% of the Ig products with expiration dates of 2023 and 2024 tested positive for anti-SARS-CoV-2 proteins, respectively. Four brands of Intravenous Ig products and one subcutaneous (SC) were found to have anti-SARS-CoV-2 proteins in the tested lots. Sample analysis of three other SC brands had no detectable anti-SARS-CoV-2 proteins. AUC values were significantly higher in products with later expiration dates used in our infusion center compared to products used in home infusions. Overall, Ig products with an expiration date between 2023 - 2024 were found to have significantly higher binding activities against SARS-CoV-2 proteins in comparison to pre-pandemic products.